Mclaren Northern Michigan Medcenter -Petoskey Nort

Summary Statement of Deficiencies D0000 The McLaren Northern Michigan MedCenter laboratory was found to be in substantial compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003). No deficiencies were cited. D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review and interview with the laboratory liaison (LL), the laboratory failed to report SARS-Co-V-2 test results as required for 6 (October - December 2020 and January - April 2021) of 6 months of patient testing. Findings include: 1. A record review revealed the laboratory was using 2 different methods of Covid testing as follows: a. BD Veritor Plus Analyzer - started testing on 10/29/2020 and tested 1100 patients. b. Cepheid GeneXpert - started testing on 11/24/2020 and tested 289 patients. 2. When queried on 4/20/2021 at 2:30 PM, TP2 informed the surveyor that the laboratory failed to report all patient testing to the health department. 3. An interview on 4/20/2021 at 2:30 pm, the LL confirmed the laboratory failed to report all patient testing to the health department, they were reporting only the positive tests. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to have a written request for patient testing from an authorized person for the hematology testing for one (#8) of 17 patient charts reviewed. Findings include: 1. On January 15, 2019 at 10:25 AM, record review conducted revealed the laboratory did not have a written request for the hematology complete blood cell count testing that was performed and documented in the electronic medical record (EMR) file. 2. During the interview on January 15, 2019 at 10:25 AM, testing personnel #12 as listed on the CMS-209 confirmed there was no written order for the hematology testing on the superbill. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to have the final microscopic urinalysis report maintained as part of the patient's chart or medical record for one (#14) of 16 patient charts reviewed. Findings include: 1. On January 15, 2019 10:40 AM, record review revealed the patient's electronic medical record (EMR) file contained a report with no results recorded on the report for the microscopic urinalysis testing. 2. During the interview on January 15, 2019 at 10:40 AM, testing personnel #12 as listed on the CMS-209 confirmed the final urinalysis microscopic report did not show any documentation of the patient's results. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require